FDA Releases Oncology Drug Guidance
The new guidance document discusses reproductive toxicity testing and labeling recommendations.
FDA published guidance on May 9, 2019 regarding the evaluation of reproductive toxicity in oncology drugs. The guidance also provides labeling recommendations on the duration of contraception needed following the end of treatment.
The guidance discusses embryo-fetal development toxicity for various types of drugs and specific populations. The use of toxicity test results, knowledge of target biology, and available data on genetically modified animals is also addressed.
Specifically, the guidance touches on genotoxic drugs, biotechnology-derived drugs, conjugated drugs, combination products, and liposomal products. Assessment of effects on fertility, pre- and postnatal development, and use in specific populations is discussed.
Source: FDA
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
